Duns Number:480420090
Device Description: 1 Stainless steel syringe1 Niti Memory shape Needle N°1 Red8 spare POM plungers N°1 Red1 1 Stainless steel syringe1 Niti Memory shape Needle N°1 Red8 spare POM plungers N°1 Red1 Niti cleaning curette N°1 Red
Catalog Number
-
Brand Name
MAP SYSTEM, MAP One (1 needle-kit)
Version/Model Number
20296
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EKI
Product Code Name
Carrier, Amalgam, Operative
Public Device Record Key
0dd8dfcb-1575-4db0-bd98-2af60df2f45b
Public Version Date
June 29, 2022
Public Version Number
1
DI Record Publish Date
June 21, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |